Cleared Traditional

K946184 - CEDIA FOLATE (NO BOIL) ASSAY

K946184 is the FDA 510(k) clearance for CEDIA FOLATE (NO BOIL) ASSAY by Microgenics Corp.. It is a Class 2 Chemistry device (product code CGN) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K946184 · Microgenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
28d
Days
Class 2
Risk

K946184 is an FDA 510(k) clearance for the CEDIA(R) FOLATE (NO BOIL) ASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on January 17, 1995 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microgenics Corp. devices

Submission Details

510(k) Number K946184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1994
Decision Date January 17, 1995
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGN Acid, Folic, Radioimmunoassay

All 50
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K946184.
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K954332 · Bayer Corp. · Jan 1996
CEDIA FOLATE (NO BOIL) ASSAY
K951155 · Microgenics Corp. · Jun 1995
RADIAS RED CELL FOLATE IMMUNOASAY
K944212 · Bio-Rad · Feb 1995
CIBA CORNING ACS FOLATE ASSAY
K943297 · Ciba Corning Diagnostics Corp. · Dec 1994
FOLIC ACID
K943705 · Diagnostic Products Corp. · Oct 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
K943149 · Beckman Coulter, Inc. · Aug 1994